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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePARADIGM REAL-TIME PUMP, PARADIGM REAL TIME REVEL INSULIN PUMP
Classification Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
PMA NumberP980022
Supplement NumberS129
Date Received11/15/2012
Decision Date02/11/2013
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for substituting the current pvc insulation material of the vibrator motor wiring of the paradigm real-time and paradigm real-time revel insulin pumps (model numbers: mmt-522, mmt-522k, mmt-523, mmt-523k, mmt-722, mmt-722k, mmt-723, and mmt-723k) with halogen-free material.
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